BACKGROUND
Relapse is very common in patients with illicit drug use disorder and contributes to a series of bad consequences that substantially impact their physical and social functions. Due to the limited existence of effective addiction treatment, the majority of patients with drug use disorder could not access help when needing. Mobile health (mHealth) offers a potential solution to improving recovery outcome for patients in community.
OBJECTIVE
This paper is a protocol for a randomized controlled trial (RCT) of a smart phone application called community-based addiction rehabilitation electronic system (CAREs). This interactive system consists of an APP for clients and a webpage for service providers, with the aim of teaching clients craving and emergency coping skills and helping service providers to improve their work efficiency and effectiveness in community.
METHODS
A randomized controlled trial (RCT) will be conducted. Sixty drug illicit users who are newly ordered to undergo community rehabilitation will be recruited from the community in Shanghai. Participants will be 1:1 randomly assigned to receive integrated community rehabilitation by using CAREs or only receiving routine community rehabilitation for 6 months. Corresponding anti-drug social workers will provide service and monitor their drug use behavior in accordance with the routine work-flow. Outcomes will be assessed at baseline and in the 6th month. The primary study outcome is the performance on illicit drug urine test which will be carried on regularly twice per week during the study period. Secondary study outcomes include longest duration of sustained abstinence, days that participants interact with anti-drug social workers, and the decrease rate of addiction-related issues severity index.
RESULTS
Recruitment is currently underway with the aim of recruiting 60 subjects with drug use disorder. Recruitment will continue until the end of 2018.
CONCLUSIONS
This is the first known trial of a smartphone-based psychotherapy program for improving recovery outcomes in illicit drug users in community. The study provides evidence for the feasibility and effectiveness of the "CAREs" system through comparing the results of the intervention group with the control group. This paper describes the design and methodology of the study.
CLINICALTRIAL
ClinicalTrials.gov NCT03451344, https://clinicaltrials.gov/ct2/show/NCT03451344
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